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Local Anesthetic

Liposomal Bupivacaine for Postoperative Pain

Phase 4
Recruiting
Led By Scott Chudnoff, MD
Research Sponsored by Maimonides Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any patient age > 18 years who is having minimally invasive robotic or laparoscopic total hysterectomy for any indication without any anesthetic block.
Be older than 18 years old
Must not have
History of hepatitis (other than hepatitis A)
Current use of systemic glucocorticosteroids (e.g. Decadron) or use of glucocorticoids within one month of enrollment into this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours after surgery
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests if Exparel injection can reduce pain during hysterectomy for benign causes; pain & meds taken at intervals to compare effectiveness.

Who is the study for?
This trial is for patients over 18 years old undergoing minimally invasive hysterectomy without prior anesthetic blocks. It excludes those who've recently used opioids, certain antidepressants, or pain medications; have significant medical risks; concurrent painful conditions; history of hepatitis (except A); allergies to specific anesthetics or propofol; recent or planned participation in other drug trials; uncontrolled psychiatric disorders; chronic analgesic use.
What is being tested?
The study tests if Exparel (liposomal bupivacaine) reduces pain when injected into the vaginal cuff before a robotic-assisted or laparoscopic total hysterectomy. Participants are randomly assigned to two groups: one receives Exparel with bupivacaine and the other receives only bupivacaine, to compare their postoperative pain scores and medication usage.
What are the potential side effects?
Potential side effects may include reactions at the injection site such as discomfort or swelling, possible nerve damage leading to numbness or weakness, allergic reactions to ingredients in Exparel or bupivacaine, nausea, vomiting, headache, fever and backache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and will have a minimally invasive hysterectomy without anesthetic block.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had hepatitis B or C in the past.
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I am currently using or have used steroids like Decadron in the past month.
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I am not allergic or unable to take acetaminophen, NSAIDs, or opioids.
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I have been using pain medication regularly for the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain reduction after surgery

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exparel and Bupivacaine GroupExperimental Treatment1 Intervention
The participants in this group will receive 10 ml of xxparel and 10 ml of bupivacaine in the vaginal cuff
Group II: Bupivacaine Only GroupActive Control1 Intervention
This group will receive 20ml of bupivicaine in the vaginal cuff

Find a Location

Who is running the clinical trial?

Maimonides Medical CenterLead Sponsor
71 Previous Clinical Trials
15,430 Total Patients Enrolled
3 Trials studying Postoperative Pain
148 Patients Enrolled for Postoperative Pain
Scott Chudnoff, MDPrincipal InvestigatorMMC
2 Previous Clinical Trials
110 Total Patients Enrolled

Media Library

Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05823363 — Phase 4
Postoperative Pain Research Study Groups: Exparel and Bupivacaine Group, Bupivacaine Only Group
Postoperative Pain Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT05823363 — Phase 4
Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05823363 — Phase 4
~30 spots leftby Dec 2025
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